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U.S. Department of Health and Human Services

Class 2 Device Recall Belly Bag Urine Collection Bag with Hip Belt.

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 Class 2 Device Recall Belly Bag Urine Collection Bag with Hip Belt. see related information
Date Posted April 22, 2013
Recall Status1 Terminated on May 01, 2014
Recall Number Z-1158-2013
Recall Event ID 64715
Product Classification Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
Product Belly Bag Urine Collection Bag with Hip Belt.

The product is a sterile urine collection device that collects urine by mechanical means when attached to an indwelling Foley or suprapubic catheter.
Code Information 02L1003282, 02M1000051, 02M1000060, 02M1001023, 02M1001024, 02M1001025, 02M1001026, 02M1001573, 02M1001574, 02M1001575, 02M1002665, 02M1002666, 02M1002667, 02M1002668, 02M1002669, 02M1003205, 02M1003206, 02M1003207, 02M1102661, 02M1102662


CATALOG NO. B1000P - 02A1100494, 02A1101101, 02A1102052, 02A1103184, 02A1201872, 02A1202793, 02B1101418, 02B1103009, 02B1202770, 02C1001701,
02C1002644, 02C1002993, 02C1201165, 02C1201848,
02C1202407, 02C1203284, 02D1002064, 02D1002756,
02E1200414, 02F1001047, 02F1001803, 02F1002745, 02F1100453, 02F1100454, 02F1203169, 02G1201452,
02G1202827, 02H1000675, 02H1001461, 02H1002834,
02H1102629, 02J1000134, 02J1003949, 02J1102523, 02K1002158, 02K1002624, 02K1101653, 02L1001192,
02L1002407, 02L1003284, 02L1101573, 02L1101575, 02M1000052, 02M1001027, 02M1001577, 02M1002671,
02M1003210,

CATALOG NO. B1000CT - 02A1100493, 02A1101100, 02A1102051, 02A1103183, 02B1101417, 02B1103008,
02E1201810, 02E1202328, 02E1202889, 02F1100452,
02G1101973, 02G1200493, 02G1200494, 02G1200495, 02G1201735, 02G1202208, 02G1202828, 02H1100292,
02H1102628, 02J1001061, 02J1001463, 02K1000442, 02K1001419, 02K1002228, 02L1001191, 02M1001576, 02M1002670, 02M1003209

Recalling Firm/
Manufacturer
Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
919-433-4829
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall
Sterile packaging may be compromised.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have any of the affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed. If you and your customers have no affected stock please complete the enclosed Recall Acknowledgement Form and fax it to 1 (866) 804-9881 Attn: Customer Service. This will allow us to document your receipt of this letter. To return product complete the enclosed Recall Acknowledgement Form and fax it to 1 (866) 804-9881 Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. If you have any other questions feel free to contact your local sales representative or Customer Service at 1 (866) 246-6990.
Quantity in Commerce 190,103
Distribution Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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